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Boots Mouth Ulcer Gel

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Document: document 0 change

180 mm

'Active ingredients

' This oral gel contains Cetylpyridinium Chloride 0.02% w/w,

Lidocaine 0.6% w/w.

Also contains: purified water, ethanol (33.9 vol %), sucrose, hypromellose, cetomacrogol 1000, star anise oil, eucalyptol, levomenthol. PL 00014/0150    Text prepared 12/14

Manufactured tor the Marketing Authorisation Holder The Boots Company PLC, Nottingham, NG2 3AA by_BCM Ltd^ Nottingham NG2_3AA________


15g_e



If you need more advice ask your pharmacist.





ARTWORK 01NLY


mm


Read all of this carton for fuH instmctions.

What this medicine is for

An antiseptic gel for the rapid relief of common mouth ulcer pain.

Before you use this medicine

XDonotuse:

• If you are allergic to any of the ingredients You can use this medicine if you are pregnant or breastfeeding.


/How to use this medicine

Check the tube seal is not broken before first use.

If it is, do not use the gel.

Pierce tube seal with end of cap.

Adults and children: Apply a small amount of gel to the affected area with a clean finger, every 3 hours during the day, if you need to.

Mouth Ulcer Gel is not suitable for teething troubles _ _ in babies.


If symptoms do not go away within 7 days talk to your doctor or dentist.

If you use too much: Talk to a pharmacist or doctor.

Possible side effects

Most people will not have problems, but some may get some. If you get any of these serious side effects, stop using the gel. See a doctor at once:

i* Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)


______«, ofside effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhragov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How to store this medicine

Do not store above 25°C. Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.


TECHNICAL INFO: PRINTER PLEASE NOTE

Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.


Trident Reference No:

BTC171242

Zen Ref:

TR898287

Category:

Healthcare

Sub-Category:

Mouth Care

Brand:

Core

Pack Type:

Carton

Variant:

Boots Mouth Ulcer Gel 15g - Carton

Action:

A

Date:

08/12/14

Country:

UK

Component Code:

XHHW7

Item Code:

22-73-950

CAD Ref No:

26x24x106mm

Printer:

N/A

Substrate:

White Carton Board

Barcode Type:

EAN 13

Barcode Number:

5000167077025

Magnification:

80%

Barcode Truncated By: 4.3 mm

(smallest bar)

Edgemark Position:

N/A

Pharmacode No/NE:

N/A

Technical Et Non Printing Items

Cutter | Guides

Colours



ARTWORK TEXT SIZE


Main Headings:

apt

Sub Headings:

7pt

Body Copy:

6.25pt


PACK 1VIOCK OP

Product Name:

Mouth Ulcer Gel

Product Licence No.:

00014/0150

Wording Ref:

MHRA approved VI dated 04/02/2014 (BTC 12G506 action C]

Status:

Internally approved

Pack Details:

Internally lacquered aluminium tube (polyamide/polyimide lacquer system) with a membrane seal fitted with a wadless

polyethylene cap or a polypropylene cap.

Pack size:

15 g

Version No.

Date Issued

Reason For Change

1

03/12/14

Correct BCM postcode to NG2 3AA


'Active ingredients

' This oral gel contains Cetylpyridinium Chloride 0.02% w/w,

Lidocaine 0.6% w/w.

Also contains: purified water, ethanol (33.9 vol %), sucrose, hypromellose, cetomacrogol 1000, star anise oil, eucalyptol, levomenthol. PL 00014/0150    Text prepared 12/14

Manufactured tor the Marketing Authorisation Holder The Boots Company PLC, Nottingham, NG2 3AA by_BCM Ltd^ Nottingham NG2_3AA________


15g_e



If you need more advice ask your pharmacist.



breastfeeding.____________________in babies.



ARTWORK 01NLY


mm


Read all of this carton for fuH instmctions.

What this medicine is for

An ar+iseptr gel fo- the rapirt relief oS common mruth 1 ulcer Gain.

'Before you use this ruedicme

XDo not us«=.

• If you are allergic to any of the ingredients You can use this medicine if you are pregnant or


/How to use this medicine

Check the tube seal is not broken before first use. iritis, do ”otMse the gel.

Pierce +|jhe se^l with end of cap.

Adults and chilaren: Apply a small amount of gel to me infected area with a clean finger, every 3 hours during the day, if you need to.

Mouth Ulcer Gel is not suitable for teething troubles


If symptoms do not go away within 7 days talk to your doctor or dentist.

If you use too much: Talk to a pharmacist or doctor.

Pos&jle s.Je e.e-ts. •

Most people ./ill not have pnoLarr.L jt some rrUyfetsor! i. ? tfyot g la /of these serious ;de effects, stop using the gel. See a doctor at once:

i* Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)


....______„ ofside effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed , Jn this leaflet. You can also report side effects directly via he Yellow Card Scheme at: www.mhragov.uk/yellowcard. 3y reporting side effects you can help provide more "formation on the safety of this medicine.

How to store this medicine

Do not store above 25°C. Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.


TECHNICAL INFO: PRINTER PLEASE NOTE

Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.


Trident Reference No:

BTC171242

Zen Ref:

TR898287

Category:

Healthcare

Sub-Category:

Mouth Care

Brand:

Core

Pack Type:

Carton

Variant:

Boots Mouth Ulcer Gel 15g - Carton

Action:

A

Date:

08/12/14

Country:

UK

Component Code:

XHHW7

Item Code:

22-73-950

CAD Ref No:

26x24x106mm

Printer:

N/A

Substrate:

White Carton Board

Barcode Type:

EAN 13

Barcode Number:

5000167077025

Magnification:

80%

Barcode Truncated By: 4.3 mm

(smallest bar)

Edgemark Position:

N/A

Pharmacode No/NE:

N/A

Technical Et Non Printing Items

Cutter | Guides

Colours


ARTWORK TEXT SIZE


BRAILLE

CONVERSION

• • • •• •

• •• ••

• • •

•

• • •• •

• • •• •

•

• • • •

•

• ••

• • • •

• • •

•

•


Boots Mouth Ulcer Gel


Main Pleadings:

8pt

Sub Headings:

7pt

Body Copy:

6.25pt

PACK 1VIOCK OP

Product Name:

Mouth Ulcer Gel

ProductLicenceNo.: 00014/0150

Wording Ref:

MHRA approved VI dated 04/02/2014 (BTC 12G506 action C]

Status:

Internally approved

Pack Details:

Internally lacquered aluminium tube (polyamide/polyimide lacquer system) with a membrane seal fitted with a wadless

polyethylene cap or a polypropylene cap.

Pack size:

15 g

03/12/14

Reason For Change


Correct BCM postcode to NG2 3AA


113 mm







ARTWORK ONLY



• • • •• • • • • •




• • • •

• ••


• • • • •


• •



TECHNICAL INFO: PRINTER PLEASE NOTE

Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.


Trident Reference No:

BTC171242

Zen Ref:

TR898287

Category:

Healthcare

Sub-Category:

Mouth Care

Brand:

Core

Pack Type:

Carton

Variant:

Boots Mouth Ulcer Gel 15g - Carton

Action:

A

Date:

08/12/14

Country:

UK

Component Code:

XHHW7

Item Code:

22-73-950

CAD Ref No:

26x24x106mm

Printer:

N/A

Substrate:

White Carton Board

Barcode Type:

EAN 13

Barcode Number:

5000167077025

Magnification:

80%

Barcode Truncated By: 4.3 mm

(smallest bar)

Edgemark Position:

N/A

Pharmacode No/NE:

N/A

Technical Et Non Printing Items

Cutter | Guides

Colours



ARTWORK TEXT SIZE


Main Headings:

apt

Sub Headings:

7pt

Body Copy:

6.25pt


BRAILLE

CONVERSION

• • • •• •

• •• ••

• • •

•

• • •• •

• • •• •

•

• • • •

•

• ••

• • • •

• • •

•

•


Boots Mouth Ulcer Gel


PACK 1VIOCK OP

Product Name:

Mouth Ulcer Gel

Product Licence No.:

00014/0150

Wording Ref:

MHRA approved VI dated 04/02/2014 (BTC 12G506 action C]

Status:

Internally approved

Pack Details:

Internally lacquered aluminium tube (polyamide/polyimide lacquer system) with a membrane seal fitted with a wadless

polyethylene cap or a polypropylene cap.

Pack size:

15 g

Version No.

Date Issued

Reason For Change

1

03/12/14

Correct BCM postcode to NG2 3AA


'Active ingredients

' This oral gel contains Cetylpyridinium Chloride 0.02% w/w, Lidocaine 0.6% w/w.

Also contains: purified water, ethanol (33.9 vol %), sucrose,


Typromellose, cetomacrogol 1000, star anise oil, eucalyptol, levomenthol. PL00014/0150    ~ ■


Text prepared 12/14 Manufactured tor the Marketing Authorisation Holder The Boots Company PLC, Nottingham, NG2 3AA by_BCM Ltd^ Nottingham NG2_3AA________


J5g.e_



000167 077025 >


mm J1


Read all of this carton for fuH instmctions.

What this medicine is for

An antiseptic gel for the rapid relief of common mouth ulcer pain.

Before you use this medicine

XDonotuse:

• If you are allergic to any of the ingredients You can use this medicine if you are pregnant or breastfeeding.

/How to use this medicine

Check the tube seal is not broken before first use.

If it is, do not use the gel.

Pierce tube seal with end of cap.

Adults and children: Apply a small amount of gel to the affected area with a clean finger, every 3 hours during the day, if you need to.

Mouth Ulcer Gel is not suitable for teething troubles _ _ in babies.___________________


If you need more advice ask your pharmacist.



If symptoms do not go away within 7 days talk to your doctor or dentist.

If you use too much: Talk to a pharmacist or doctor.

Possible side effects

Most people will not have problems, but some may get some. If you get any of these serious side effects, stop using the gel. See a doctor at once:

i* Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)


of side effects


If you get any side effects, talk to your doctor, pharmacist ------e. This includes any possible side effects


or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard, By reporting side effects you can help provide more irmation on the safety of this medicine.


How to store this medicine

Do not store above 25°C. Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.



ARTWORK ONLY



TECHNICAL INFO: PRINTER PLEASE NOTE

Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.

Category:

Healthcare

Sub-Category:

Mouth Care

Brand:

Core

Pack Type:

Carton

Variant:

Boots Mouth Ulcer Gel 15g - Carton

Action:

A

Date:

08/12/14

Country:

UK

Component Code:

XHHW7

Item Code:

22-73-950

CAD Ref No:

26x24x106mm

Printer:

Substrate:

White Carton Board

Barcode Type:

EAN 13

Barcode Number:

5000167077025

Magnification:

80%

Barcode Truncated By: 4.3 mm

(smallest bar)

Edgemark Position:

N/A

Pharmacode No/NE:

N/A

Technical Et Non Printing Items

Cutter | Guides

Colours


ARTWORK TEXT SIZE


Main Headings:

apt

Sub Headings:

7pt

Body Copy:

6.25pt

PACK MOCK OP

Product Name:

Mouth Ulcer Gel

Product Licence No.:

00014/0150

Wording Ref:

MHRA approved VI dated 04/02/2014 (BTC 12G506 action C]

Status:

Internally approved

Pack Details:

Internally lacquered aluminium tube (polyamide/polyimide lacquer system) with a membrane seal fitted with a wadless

polyethylene cap or a polypropylene cap.

Pack size:

15 g

Version No.

Date Issued

Reason For Change

1

03/12/14

Correct BCM postcode to NG2 3AA

ARTWORK ONLY




113 mm








7


TECHNICAL INFO: PRINTER PLEASE NOTE

Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.


Trident Reference No: BTCl 71242

Zen Ref:

TR898287

Category:

Healthcare

Sub-Category:

Mouth Care

Brand:

Core

Pack Type:

Carton

Variant:

Boots Mouth Ulcer Gel 15g - Carton

Action:

A

Date:

08/12/14

Country:

UK

Component Code:

XHHW7

Item Code:

22-73-950

CAD Ref No:

26x24x106mm

Printer:

N/A

Substrate:

White Carton Board

Barcode Type:

EAN 13

Barcode Number:

5000167077025

Magnification:

80%

Barcode Truncated By:

4.3 mm

(smallest bar)

Edgemark Position:

N/A

Pharmacode No/NE:

N/A

Technical Et Non Printing Items

Cutter | Guides

Colours



ARTWORK TEXT SIZE


Main Headings:

apt

Sub Headings:

7pt

Body Copy:

6.25pt


PACK MOCK OP

Product Name:

Mouth Ulcer Gel

Product Licence No.:

00014/0150

Wording Ref:

MHRA approved VI dated 04/02/2014 (BTC 12G506 action C]

Status:

Internally approved

Pack Details:

Internally lacquered aluminium tube (polyamide/polyimide lacquer system) with a membrane seal fitted with a wadless

polyethylene cap or a polypropylene cap.

Pack size:

15 g

Version No.

Date Issued

Reason For Change

1

03/12/14

Correct BCM postcode to NG2 3AA


M



MOUTH ULCER fie/

Cetylpyridinium Chloride, Lidocaine

V Rapidly relieves mouth ulcer pain y Soothing antiseptic y Adults and children


60 mm



Read all of the carton for full instructions.

/How to use this medicine

Pierce tube seal with end of cap. Adults and children: Apply a small amount of gel to the affected area with a clean finger, every 3 hours during the day, if you need to. Mouth Ulcer Gel is not suitable for teething trouble in babies.

How to store this medicine

Do not store above 25°C.

Keep all medicines out of the sight and reach of children.

Active ingredients: This oral gel contains Cetylpyridinium Chloride 0.02% w/w, Lidocaine 0.6% w/w.

Also contains: purified water, ethanol (33.9 vol %), sucrose, hypromellose, o cetomacrogol 1000, star anise oil, J eucalyptol, levomenthol.    ^

pl 00014/oi so    15gfc?

The Boots Company PLC PWVQ1 Nottingham NG2 3AA 22-73-950

ARTWORK ONLY

ARTWORK TEXT SIZE


Main Headings:    7pt

Sub Headings:    7pt

Body Copy:    6pt

PACK MOCK OP

Product Name: Mouth Ulcer Gel Product Licence No.: 00014/0150 Wording Ref: BTC126493 vC 27/06/13 Status: MHRA approved Pack Size: 15 g

Pack Details: Internally lacquered aluminium tube (polyamide/polyimide lacquer system)

Version No.

Date Issued

Reason For Change

1

04/02/2014

Re-design, BCM address and Yellow card update


Trident Reference No: BTCl 26493

Zen Ref:

TR694315

Category:

Healthcare

Sub-Category:

Mouth Care

Brand:

Core

Pack Type:

Tube

Variant:

Boots Mouth Ulcer Gel 15g - Tube

Action:

D

Date:

10/02/14

Country:

UK

Component Code:

PWVQ1

Item Code:

22-73-950

CAD Ref No:

19mm diameter x 104mm

Printer:

N/A

Substrate:

White Aluminum

Barcode Type:

N/A

Barcode Number:

N/A

Magnification:

N/A

Barcode Truncated By: (smallest bar)

N/A

Edgemark Position:

N/A

Pharmacode No/NE:

1011(26)

Technical Et Non Printing Items Cutter | Guides

Colours


I


Pattern Gloss Varnish

_5_



TECHNICAL INFO: PRINTER PLEASE NOTE

Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.